Orthotic device and method of use

ABSTRACT

An orthotic device and method of use are disclosed for suspending toes of a wearer&#39;s foot off of a sole of footwear. The orthotic device includes a bottom surface, a top surface, and a distal end. The bottom surface is adapted to be affixed to a sole of protective footwear. The top surface is adapted to be adjacent to the foot when the foot is within the protective footwear and to suspend toes of the foot off of the sole when the foot is in a resting position within the protective footwear. The distal end defines ends of the bottom surface and the top surface, the distal end being substantially aligned with metatarsophalangeal joints of the foot when the foot is within the protective footwear.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application No. 62/175,841, entitled, “ORTHOTIC DEVICE ANDMETHOD OF USE,” filed Jun. 15, 2015, the entirety of which is herebyincorporated by reference herein, including the drawings.

FIELD OF THE INVENTION

The present disclosure generally relates to an orthotic insert forfootwear, a method of using the same, and footwear including the same.

BACKGROUND

Foot maladies can be difficult to treat and heal because of thecontinued need of the patient to ambulate. Particularly for maladies ofthe phalanges (toes), repeated loading on the toes can cause delays andsometimes even prevent proper healing, which may lead to serious issues(e.g., digital amputation). Further, diabetic foot problems, such asulcerations, infections, and gangrene, remain a common cause ofhospitalization for people that suffer from diabetes (e.g., diabetesmellitus types I and II). Medical costs associated with routine ulcercare, infection treatment, and amputations cost billions of dollarsannually.

Certain protective footwear can be worn to offload areas of the footpost operatively, and in other situations necessitating offloading, suchas when treating foot fractures and ulcers. Traditionally, suchprotective footwear has a firm, rocker bottom to minimize bendingthrough the entire foot by rocking during gait, as opposed to pushingoff. Specific protective footwear may have soles that have cut-outsections under the heel or the forefoot to transfer more weight to theforefoot or the heel. Other footwear has removable foam pegs within theinsole to off-weight selected areas of the foot. Yet, in such protectivefootwear, a thin fabric section still exists at the locations where thefoam pegs have been removed. Thus, such protective footwear cannot floatthe toes.

Although the above-described protective footwear generally offloadsweight, such protective footwear does not offload weight specificallyfrom the toes of the foot. Accordingly, proper offloading, specificallywith respect to the toes, remains a large challenge for physicians andclinicians dealing with diabetic foot ulcers and other similar maladiesof the foot, such as the result of surgery and/or fractures.

A need exists, therefore, for an orthotic insert, sole, and/or footwearthat suspends the toes.

SUMMARY

Aspects of the present concepts include an orthotic device adapted to beplaced beneath metatarsals of a foot. The device includes a bottomsurface, a top surface, and a distal end. The bottom surface is adaptedto be affixed to a sole of protective footwear. The top surface isadapted to be adjacent to the foot when the foot is within theprotective footwear and to elevate toes of the foot off of the sole whenthe foot is in a resting position within the protective footwear. Thedistal end defines ends of the bottom surface and the top surface; thedistal end being substantially aligned with metatarsophalangeal jointsof the foot when the foot is within the protective footwear. Theproximal ends of the bottom surface and the top surface can be under thecentral arch area of the foot.

Additional aspects of the present concepts include an orthotic apparatusincluding a soft insole and a wedge. The soft insole is adapted to beplaced on a rigid sole of footwear. The wedge is adapted to be placedbeneath a foot wearing the footwear. The wedge includes a first end anda second end opposite the first end. The first end is substantiallyaligned with metatarsophalangeal joints of the foot. The second end isproximal to the first end relative to the foot, and the wedge suspendstoes of the foot above a lower surface of the footwear.

Another aspect of the present concepts is a method of elevating one ormore toes of a foot within footwear. The method includes attaching awedge having a top surface and a bottom surface to a sole of thefootwear such that a distal end of the wedge relative to the foot isaligned with and below metatarsophalangeal joints of the foot with thefoot within the footwear. The method further includes suspending the oneor more toes off of the sole based on the wedge being within thefootwear and aligned with the metatarsophalangeal joints of the footwhen the foot is within the footwear.

The above summary is not intended to represent each embodiment or everyaspect of the present disclosure. Rather, the foregoing summary merelyprovides an exemplification of some of the novel aspects and featuresset forth herein. The above features and advantages, and other featuresand advantages of the present disclosure, will be readily apparent fromthe following detailed description of representative embodiments andmodes for carrying out the present embodiments when taken in connectionwith the accompanying drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure will be better understood from the following descriptionof exemplary embodiments together with reference to the accompanyingdrawings, in which:

FIG. 1 shows protective footwear, in accord one embodiment.

FIG. 2 shows a soft insole of the protective footwear of FIG. 1, inaccord one embodiment.

FIG. 3A shows a perspective view of a wedge that suspends toes of afoot, in accord with some aspects of the present concepts.

FIG. 3B shows a cross-section view of the wedge of FIG. 3A, in accordwith some aspects of the present concepts.

FIG. 4A shows a perspective view of the wedge of FIGS. 3A and 3Bpositioned on the soft insole of FIG. 2, in accord with some aspects ofthe present concepts.

FIG. 4B shows a cross-section view of the wedge and soft insole of FIG.4A, in accord with some aspects of the present concepts.

FIG. 5A shows a perspective view of a wedge relative to a soft sole, inaccord with some additional aspects of the present concepts.

FIG. 5B shows a cross-section view of the wedge and soft sole in FIG.5A, in accord with some additional aspects of the present concepts.

FIG. 6A shows a perspective view of a wedge relative to a soft sole withan insert, in accord with some additional aspects of the presentconcepts.

FIG. 6B shows a cross-section view of the wedge relative to the softsole with the insert in FIG. 6A, in accord with some additional aspectsof the present concepts.

FIGS. 7A-7C show cross-section views of wedges having various shapes, inaccord with some additional aspects of the present concepts.

FIG. 8A shows a perspective view of a wedge and soft sole within thefootwear of FIG. 1, in accord with some aspects of the present concepts.

FIG. 8B shows a cross-sectional slice of the wedge, soft sole, and rigidbase of the footwear of FIG. 8A, in accord with some aspects of thepresent concepts.

FIG. 8C shows a cross-sectional slice of the wedge, soft sole, and rigidbase of the footwear of FIG. 8B, in accord with some additional aspectsof the present concepts.

FIG. 9 shows a cross-section view of a foot within the footwear of FIGS.8A-8C, in accord with some aspects of the present concepts.

While the disclosure is susceptible to various modifications andalternative forms, specific implementations thereof have been shown byway of example in the drawings and will be described in detail herein.It should be understood, however, that it is not intended to limit thedisclosure to the particular forms disclosed, but on the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit of the present disclosure.

DESCRIPTION

The elements and features within the present disclosure are susceptibleto embodiment in many different forms. There are shown in the drawings,and will herein be described in detail, representative embodiments withthe understanding that the present disclosure is to be considered as anexemplification of the principles of the present element and featuresdisclosed herein and is not intended to limit the broad aspects to theembodiments illustrated. To that extent, elements and features that aredisclosed, for example, in the Abstract, Summary, and DetailedDescription sections, but not explicitly set forth in the claims, shouldnot be incorporated into the claims, singly or collectively, byimplication, inference, or otherwise. For purposes of the presentdetailed description, unless specifically disclaimed: the singularincludes the plural and vice versa; and the word “including” means“including without limitation.”

Referring to FIG. 1, FIG. 1 shows a perspective view of protectivefootwear 100, according to one embodiment. The protective footwear 100is worn on a foot (not shown) of a wearer during treatment and/orhealing of a malady of the foot. Such protective footwear 100 representsone example of the above-described, currently existing protectivefootwear worn by patients suffering from foot maladies. By way ofexample, and without limitation, the protective footwear 100 can bevarious protective footwear made by DARCO, such as the MedSurg™ shoe,the OrthoWedge® off-loading shoe, the HeelWedge™, and the PegAssist™insole.

The protective footwear 100 includes a rigid sole 102 that spans fromthe front 100 a of the protective footwear 100 to the rear 100 b of theprotective footwear 100. The rigid sole 102 is a firm, rocker bottomthat minimizes bending through the entire foot and provides for overallsupport of the foot during ambulation. The protective footwear 100includes straps 104 to secure the protective footwear 100 to the foot.The straps 104 can include, for example, straps 104 a and 104 b thatselectively engage across the top of the midfoot/forefoot and straps 104c and 104 d that selectively engage around the hindfoot/ankle. However,according to some embodiments, the protective footwear 100 can includeother mechanisms for securing the protective footwear 100 to the wearer,such as laces, buttons, Velcro®, etc.

Above the rigid sole 102 is a soft insole 106. The soft insole 106 spansfrom the front 100 a of the protective footwear 100 to the rear 100 b ofthe protective footwear 100. According to some embodiments, the rigidsole 102 includes a raised ridge 102 a that spans the perimeter of therigid sole 102. The raised ridge 102 a forms a recess (not shown) of therigid sole 102 that accepts the soft insole 106 such that the softinsole 106 lays on the rigid sole 102 and is surrounded by the raisedridge 102 a.

FIG. 2 shows the soft insole 106 removed from the protective footwear100, according to one embodiment. Thus, according to some embodiments,the soft insole 106 is removable from the rigid sole 102. Generally, theprotective footwear 100 and, therefore, the soft insole 106 come inseveral sizes (e.g., small, medium, and large) to accommodate fordifferent foot sizes. Thus, the dimensions of the rigid sole 102 and thesoft insole 106 vary depending on the size of the protective footwear100 used for the wearer.

Although the protective footwear 100 with the soft insole 106 configuredas shown in FIGS. 1 and 2 allows for offloading weight with respect tothe foot in general, such protective footwear 100 does not offloadweight from the toes of the wearer. Moreover, regardless of whetherweight is offloaded from the toes, such protective footwear 100 contactsthe toes during ambulation and use in general. The continued contact canexacerbate and/or prevent proper healing of the toes, such as in thecase of ulcers. By way of example, and without limitation, although thesoft insole 106 provides cushioning to a foot when the foot is securedto the protective footwear 100, the cushioning may not be sufficient toallow for proper treatment and/or healing of maladies of the toes, suchas ulcers, and the soft insole 106 still contacts the toes.

According to aspects of the present concepts, a wedge is disclosed thatsuspends the toes of the wearer's foot off of a surface of protectivefootwear, or footwear in general. The toes are suspended forward fromthe metatarsophalangeal joints of the foot. By the wedge beingpositioned from behind the ball of the foot and inclining to just behindthe toes, the wearer can ambulate without contact between the toes and abottom portion of the footwear below the toes. Thus, the toes do notexperience loading and/or wear by contact with the footwear and areplaced in a position to maximize healing.

As described in greater detail below, according to some embodiments, thewedge can be added to currently existing footwear, such as by beingattached to existing soft insoles 106 of the protective footwear 100.Alternatively, the wedge can be integral with a soft insole thatreplaces the currently existing soft insole 106 within the protectivefootwear 100. Additionally, according to some embodiments, the wedge canbe integral with the soft insole 106, or a similar soft insole, that isalso integral within similar footwear as the protective footwear 100.According to the various embodiments, the wedge positions the toesduring ambulation and can be used, for example, post operation and/orduring healing of one or more maladies of the toes.

FIGS. 3A and 3B show a wedge 300 for insertion within footwear, withFIG. 3B showing the wedge 300 in cross section along the line 3B-3B inFIG. 3A, in accord with aspects of the present concepts. The wedge 300includes a front 300 a and a rear 300 b. The wedge 300 further includesa top surface 302. The top surface 302 includes a level portion 302 aand an inclined portion 302 b. The top surface 302 is adapted tointerface with the foot when the foot is within footwear such that thetop surface 302 elevates and suspends the toes of the foot off of a soleof the footwear below the toes. The inclined portion 302 b begins at therear 300 b of the wedge 300 and extends to, for example, a point 304between the rear 300 b and the front 300 a of the wedge 300. The pointcan be at various points between the rear 300 b and the front 300 a ofthe wedge 300, and can also be referred to as a midpoint 304 withoutrequiring that the point 304 be in the middle of the top surface 302.The angle of the incline θ₁ of the inclined portion 302 b can be 5 to 40degrees, such as 10 degrees.

The level portion 302 a begins at the distal end of the inclined portion302 b at the point 304, and extends to the front 300 a of the wedge 300.The level portion 302 a spans a length of the top surface 302 to providea contact surface for the ball of the foot to distribute weight evenlyand to reduce or prevent pressure points. According to some embodiments,the level portion 302 a spans two thirds of the length of the topsurface 302, and the inclined portion 302 b spans the remaining onethird of the length of the top surface 302. However, the lengths of thelevel portion 302 a and the inclined portion 302 b can vary withoutdeparting from the spirit and scope of the present disclosure.

According to some embodiments, although the midpoint 304 is illustratedas an abrupt transition from the inclined portion 302 b to the levelportion 302 a, the transition at the midpoint 304 can be gradual, suchas rounded, to reduce or prevent any discomfort caused by continuedcontact of the underside of the foot by the midpoint 304.

The wedge 300 also includes a bottom surface 306. The bottom surface 306is adapted to interface with the sole of footwear when the wedge 300 isinserted within the footwear. The wedge 300 also includes a verticaledge 300 c and, according to some embodiments, also includes a verticaledge 300 d. The vertical edges 300 c and 300 d separate the top surface302 from the bottom surface at the distal and proximal ends of the wedge300, respectively.

The overall dimensions of the wedge 300 vary depending on the size ofthe foot or the footwear. With respect to the length, the length of thetop surface 302 of the wedge 300 is configured to provide a base for theball of the foot to rest on while off-loading and suspending the toes.According to some embodiments, the length of the wedge 300 can be suchthat the vertical edge 300 d or the rear 300 b (e.g., proximal end) isunder the central arch area of the foot and the vertical edge 300 c orthe front 300 a (e.g., distal end) is aligned with themetatarsophalangeal joints of the foot. By way of example, the length ofthe wedge 300 can be 2 to 4 cm, such as 2.5 cm, for average foot sizes.The width of the wedge 300 can be substantially the same width as a soleto which the wedge 300 is integral with or affixed. The width isconfigured to provide a base for substantially the entire ball of thefoot to evenly distribute the weight. Further, the wedge 300 can beformed of various materials found within footwear, such as materialsgenerally used for forming soft insoles of footwear including, forexample, padding materials.

Although the wedge 300 is illustrated as having a substantially straightfront 300 a, according to some embodiments the front 300 a may havealternative shapes and/or configurations. For example, the dimensions ofthe foot generally cause the ends of the toes to form a parabolic shape,with the long toe adjacent to the hallux (big toe) at the apex of theparabola. The metatarsals also form a generally parabolic shape, withthe distal aspect of the metatarsal of the long toe at the apex of theparabola. According to some embodiments, the front 300 a of the wedge300 can have a similar parabolic shape to correspond to the parabolicshape of the metatarsals within a wearer's foot. According to suchembodiments, the vertical edge 300 c can be formed according to aparabolic shape to be uniformly positioned with respect to, for example,the distal aspect of all five metatarsals.

Referring to FIG. 4A, FIG. 4A is a perspective view that shows the wedge300 affixed to the soft insole 106 from the protective footwear 100 ofFIG. 1. The wedge 300 is affixed to the soft insole 106 at a location ofthe soft insole 106 that corresponds to below the metatarsals of thefoot. More specifically, the wedge 300 is positioned such that the front300 a of the wedge 300 is aligned with the midpoint to the distal aspectof the metatarsophalangeal joints of the foot when the foot is withinthe protective footwear 100. By aligning the front 300 a of the wedge300 with the metatarsophalangeal joints of the foot, the wedge 300elevates and suspends the toes of the foot off of the soft insole 106.Accordingly, pressure is not applied to the toes from the protectivefootwear 100 with the toes at rest and during general ambulation, andthe wedge 300 reduces or prevents contact between the toes and the softinsole 106 below the toes. According to some embodiments, such as theprotective footwear 100 including an open top, the toes also do notcontact a top surface of the protective footwear 100.

Referring to FIG. 4B, FIG. 4B shows a cross-section view of the wedge300 affixed to the soft insole 106 along the ling 4B-4B of FIG. 4A, inaccord with aspects of the present concepts. According to someembodiments, the thickness T₁ of the soft insole 106 can be, for example¼ to ½ of an inch, such as ⅜ of an inch, and the thickness T₂ of thewedge 300 can be the same thickness of the soft insole 106, or thickerthan the soft insole 106, such as, for example, ⅜ to ¾ of an inch, suchas ½ of an inch. However, based on the comfort tolerances of the wearer,the upper limit of the thickness T₂ of the wedge 300 can be larger, suchas 1 inch, to suspend the toes farther off of the soft insole 106. Thus,according to some embodiments, the thickness T₁ of the soft insole 106can be equal to or less than the thickness T₂ of the wedge 300.

As described above, the wedge 300 can be affixed to the soft insole 106.Alternatively, according to some embodiments, the soft insole 106 can beformed to include the wedge 300 as an integral part of the soft insole106, such that the soft insole 106 and the wedge 300 are formed as asingle piece. Further, according to some embodiments, the wedge 300 canbe affixed to or be an integral part of other soles.

As illustrated, the soft insole 106 is substantially flat reward fromthe rear 300 b of the wedge 300. By being flat, the soft insole 106provides a stable platform for the wearer's foot when supported by thecombination of the sole 501 and the wedge 300. With the soft insole 106rearward from the wedge 300 flat rather than, for example, raisedrelative to the bottom surface 306 of the wedge 300, the weight of thewearer is not shifted forward. Thus, the substantially flat soft insole106 at the same level as the bottom surface 306 of the wedge 300 reducesor prevents weight from being shifted forward, which could otherwiseimpact the ability of the toes to remain suspended during ambulation.

Referring to FIG. 5A, FIG. 5A shows the wedge 300 affixed to a sole 501,as an alternative to the soft insole 106, in accord with aspects of thepresent concepts. The sole 501 can be formed of the same material as thesoft insole 106 described above. The sole 501 is formed (e.g., sized) toextend from the rear 100 b of the protective footwear 100 to just behindthe toes when inserted in, for example, the protective footwear 100 inplace of the soft insole 106. Thus, in comparison to the soft insole106, for example, the sole 501 excludes a portion 503 corresponding tothe soft insole 106 forward of the wedge 300 in FIGS. 3A and 3B. Byexcluding the portion 503 of the soft insole 106, the toes of thewearer's foot can be suspended even farther off of a surface below thetoes, such as a surface of footwear.

Referring to FIG. 5B, FIG. 5B is a cross-section view along the line5B-5B of FIG. 5A, in accord with aspects of the present concepts. Thefront 300 a of the wedge 300 is aligned with the front edge 501 a of thesole 501. The thickness T₃ of the sole 501 can be, for example ¼ to ½ ofan inch, such as ⅜ of an inch. According to some embodiments, thethickness T₃ of the sole 501 can be the same thickness T₁ of the softinsole 106. The thickness T₄ of the wedge 300 with respect to beingpositioned on the sole 501 can be the same thickness of the sole 501, orcan be thicker than the sole 501, such as, for example, ⅛ to ¾ of aninch, such as ½ of an inch. Similar to above, based on the comforttolerances of the wearer, the upper limit of the thickness T₄ of thewedge 300 with respect to being positioned on the sole 501 can belarger, such as 1 inch, to suspend the toes farther off of any solebelow the toes (e.g., rigid sole 102). According to some embodiments,the thickness T₄ can be less than the thickness T₂ of the soft insole106 based on the lack of the sole 501 below the toes with the wedge 300positioned on the sole 501. For example, the toes are suspended theadditional thickness T₃ of the sole 501 without the portion 503 ascompared to the soft insole 106.

The wedge 300 is positioned relative to the sole 501 such that the front300 a of the wedge 300 is substantially even with the front edge 501 aof the sole 501, and the rear 300 b of the wedge 300 is positioned tocorrespond with the rear forefoot or midfoot of the foot when the footand the sole 501 are within footwear.

As described above, according to some embodiments, the wedge 300 can beintegral to the sole 501. Alternatively, according to some embodiments,the wedge 300 can be affixed to the sole 501 according to variousmethods. By way of example, and without limitation, the wedge 300 can beaffixed to the sole 501 using double-sided tape, glue, or any other typeof adhesive and/or boding agent.

Although primarily described as a wedge, according to some embodiments,the wedge 300 can instead be in the shape of a slab. For example, ratherthan having the top surface 302 with the inclined portion 302 b, theentire top surface 302 can be level according to the level portion 302a. With the wedge 300 in the shape of a slab, and based on the materialthat forms the wedge 300, pressure from the foot on the wedge 300 withinfootwear can shape the slab to have an inclined top surface, such as theinclined portion 302 b, after repeated use and pressure from the footshaping the slab.

According to some embodiments, the sole 501 can be formed by modifyingthe soft insole 106. Specifically, the soft insole 106 can be modifiedby removing a portion of the soft insole 106 corresponding to theportion 503 described above. By way of example, and without limitation,a user (e.g., physician, clinician, technician, wearer, etc.) can removea portion of the soft insole 106 corresponding to the portion 503 thatis aligned with the metatarsophalangeal joints and extends forward. Theportion of the soft insole 106 can be removed according to any method,such as cutting the soft insole 106 with scissors, to form the sole 501from the remaining portion of the soft insole 106. Additionally,according to some embodiments, the wedge 300 can be formed based on theportion removed from the soft insole 106. The portion removed from thesoft insole 106 can be shaped according to the above-describeddimensions and shape of the wedge 300 and can be affixed to a sole asthe wedge 300.

FIG. 6A shows the sole 501 of FIG. 5A with an insert 601, in accord withsome aspects of the present concepts. As shown, the insert 601accommodates for the difference in the length of the sole 501 ascompared to the soft insole 106. Placement of the insert 601 in front ofthe sole 501 and beneath the toes can prevent any contact between thetoes and another surface beneath the insert 601, such as the rigid sole102 (discussed below). According to some embodiments, the insert 601 canbe formed of a material that is softer than the material that forms thesole 501. By way of example, and without limitation, the insert 601 canbe formed of PPT foam padding.

FIG. 6B is a cross-section view along the line 6B-6B in FIG. 6A, inaccord with aspects of the present concepts. The front 300 a of thewedge 300 is aligned with the front edge 501 a of the sole 501. Theinsert 601 has a thickness T₅ that is less than the thickness T₃ of thesole 501. By way of example, and without limitation, the thickness T₅ ofthe insert 601 can be 1/16 to 3/16 of an inch, such as ⅛ of an inch.With the addition of the insert 601, the thickness T₄ of the wedge 300can be increased to compensate for the additional thickness of theinsert 601.

According to some embodiments, the shape of the wedge 300 can vary.FIGS. 7A-7C show wedges of varying shapes, in accord with aspects of thepresent concepts. Although the wedges of varying shapes are all shownwith respect to the sole 501, the wedges can be affixed or integral withany sole discussed herein and equivalents thereof.

Referring to FIG. 7A, FIG. 7A shows an embodiment of a wedge 720 incross-section relative to the sole 501, according to some aspects of thepresent concepts. The wedge 720 includes a front edge 722 a at the front720 a and a back edge 722 b at the back 720 b. Further, the wedge 720includes a top surface 724. The top surface 724 is flat and is inclinedupward from the rear 720 b to the front 720 a of the wedge 720. Similarto the wedge 300, the top surface 724 at the rear 720 b of the wedge 720is elevated off of the sole 501 based on the presence of the rear edge722 b. The front edge 722 a of the wedge 720 is generally aligned withthe front edge 501 a of the sole 501. The angle θ₂ of the incline of thetop surface 724 provides a gradual incline for comfort of the wearer. Byway of example, and without limitation, the angle θ₂ of the incline ofthe top surface 724 is 5 to 40 degrees, such as 10 degrees.

FIG. 7B shows another embodiment of a wedge 740 in cross-sectionrelative to the sole 501, according to some aspects of the presentconcepts. The wedge 740 includes a front edge 742 a at the front 740 a.Further, the wedge 740 includes a top surface 744. The top surface 744includes a level portion 744 a and an inclined portion 744 b. Theinclined portion 744 b begins contiguous to the sole 501 at the rear 740b of the wedge 740. The inclined portion 744 b inclines upward toward amidpoint 746 at which the top surface 744 transitions from the inclinedportion 744 b to the level portion 744 a. The position and formation ofthe midpoint 746 is similar to the midpoint 304 discussed above. Thelevel portion 744 a extends from the inclined portion 744 b to the frontedge 742 a of the wedge 740. The front edge 742 a of the wedge 740 isgenerally aligned with the front edge 501 a of the sole 501.

The level portion 744 a spans a length of the top surface 744 to providea contact surface for the ball of the foot to distribute weight evenlyand to prevent causing any pressure points. According to someembodiments, the level portion 744 a spans two thirds of the length ofthe top surface 744, and the inclined portion 744 b spans the remainingone third of the length of the top surface 744. However, the lengths ofthe level portion 744 a and the inclined portion 744 b can vary withoutdeparting from the spirit and scope of the present disclosure. The angleθ₃ of the inclined portion 744 b provides a gradual incline for comfortof the wearer. By way of example, and without limitation, the angle θ₃can be 5 to 40 degrees, such as 30 degrees.

FIG. 7C shows another embodiment of a wedge 760 in cross-sectionrelative to the sole 501, according to some aspects of the presentconcepts. The wedge 760 includes a front edge 762 a at the front 760 a.Further, the wedge 760 includes a top surface 764. The top surface 764is flat and is inclined upward from the rear 760 b to the front 760 a ofthe wedge 760. The top surface 764 begins contiguous to the sole 501 atthe rear 760 b of the wedge 760 and inclines up to the front edge 760 aof the wedge 760. The front edge 762 a of the wedge 760 is generallyaligned with the front edge 501 a of the sole 501. The angle θ₄ of theincline of the top surface 764 provides a gradual incline for comfort ofthe wearer. By way of example, and without limitation, the angle θ₄ canbe 5 to 40 degrees, such as 20 degrees.

FIG. 8A shows protective footwear 800, in accord with aspects of thepresent concepts. The protective footwear 800 is similar to theprotective footwear 100 of FIG. 1, but for the sole 501 being in placeof the soft insole 106. FIG. 8B shows a cross-sectional slice of theprotective footwear 800 along the line 8B-8B within FIG. 8A, and FIG. 8Cshows a cross-sectional slice of the protective footwear 800 along theline 8C-8C within FIG. 8B, in accord with aspects of the presentconcepts.

The sole 501 with the wedge 300 fits within the protective footwear 800above the rigid sole 102 and is surrounded by the ridge 102 a. With thewedge 300 and the sole 501 within the protective footwear 800, the toesof the foot are elevated upward and suspended off of the rigid sole 102forward of the wedge 300. Suspending the toes off of a surface of theprotective footwear 800 (e.g., the rigid sole 102) reduces or eliminatesthe extent or the occurrence of contact between the toes and thesurface. The reduced or eliminated extent or occurrence of contactmaximizes healing of maladies (e.g., ulcers, etc.) of the toes. Contacton the foot is directed away from the toes to other contact surfaces ofthe foot, such as the ball of the foot or the heel. Moreover, by thewedge 300 suspending the toes above the rigid sole 102 rather than, forexample, removing the rigid sole below the toes, the footprint of theprotective footwear 800 is not modified and the rigid sole 102 stillprovides the same length of contact surface with the ground.

FIG. 9 shows a cross-section, such as along line 8B-8B of FIG. 8A, of afoot 900 within the protective footwear 800, in accord with aspects ofthe present concepts. As shown, the foot includes the metatarsals 901and the phalanges (toes) 903. The wedge 300 is positioned below themetatarsals 901 such that the front 300 a of the wedge 300 is alignedwith the metatarsophalangeal joints of the foot 900, such as alignedwith the midpoint to distal aspect of the metatarsophalangeal joints.With the wedge 300 positioned as shown and described, the phalanges 903are suspended off of the rigid sole 102. Moreover, even with theoptional insert 601 included within the protective footwear 800, thephalanges 903 also are suspended off of the insert 601. Thus, with thewedge 300 within the protective footwear 800, a wearer of the protectivefootwear 800 can ambulate while reducing or preventing contact betweenthe toes and a surface of the protective footwear 800 below the toes,such as the insert 601 or the rigid sole 102. Further, with the rigidsole 102 below the toes, the footprint (e.g., length) of the protectivefootwear 800 remains the same despite the toes being suspended.

While the present disclosure has been described with reference to one ormore particular implementations, those skilled in the art will recognizethat many changes may be made thereto without departing from the spiritand scope of the present disclosure. The above describedimplementations, and obvious variations thereof, are contemplated asfalling within the spirit and scope of the disclosure.

What is claimed is:
 1. A device adapted to be placed beneath metatarsalsof a foot comprising: a bottom surface being adapted to be affixed to asole of protective footwear; a top surface being adapted to be adjacentto the foot when the foot is within the protective footwear and tosuspend toes of the foot off of the sole when the foot is in a restingposition within the protective footwear; and a distal end defining endsof the bottom surface and the top surface, the distal end beingsubstantially aligned with metatarsophalangeal joints of the foot whenthe foot is within the protective footwear.
 2. The device of claim 1,wherein the top surface includes a level portion and an inclinedportion, the level portion being substantially level from the distal endto a midpoint of the top surface, and the inclined portion beinginclined downward from the midpoint to a proximal end of the topsurface.
 3. The device of claim 2, wherein the inclined portion of thetop surface is contiguous to the sole at the proximal end of the topsurface.
 4. The device of claim 2, further comprising: a proximal edgedefining opposite ends of the top surface and the bottom surface,wherein the proximal edge separates the inclined portion of the topsurface from the sole at the proximal end of the top surface.
 5. Thedevice of claim 1, wherein the top surface is inclined from a proximalend of the top surface to the distal end.
 6. The device of claim 5,wherein the top surface is contiguous to the sole at the proximal end ofthe top surface.
 7. The device of claim 5, further comprising: aproximal edge defining opposite ends of the top surface and the bottomsurface, wherein the proximal edge separates the top surface from thesole at the proximal end of the top surface.
 8. An apparatus comprising:a soft insole adapted to be placed on a rigid sole of footwear; and awedge adapted to be placed beneath a foot wearing the footwear, thewedge having a first end and a second end opposite the first end, thefirst end being substantially aligned with metatarsophalangeal joints ofthe foot, the second end being proximal to the first end relative to thefoot, and the wedge suspending toes above a lower surface of thefootwear below the toes.
 9. The apparatus of claim 8, wherein the secondend is aligned with or forward of a midfoot of the foot.
 10. Theapparatus of claim 8, wherein the wedge has a top surface and a bottomsurface, the bottom surface being adapted for being affixed to the softinsole and the top surface being adapted to be adjacent to the foot andhaving at least an inclined portion that elevates and suspends the toesoff of the soft insole and the rigid sole with the toes in a restingposition within the footwear.
 11. The apparatus of claim 10, wherein theinclined portion of the top surface is contiguous to the soft insole ata proximal end of the top surface.
 12. The apparatus of claim 10,wherein the wedge includes a proximal edge that defines ends of the topsurface and the bottom surface, and the proximal edge separates theinclined portion of the top surface from the soft insole at a proximalend of the top surface.
 13. The apparatus of claim 10, wherein the topsurface is inclined from a proximal end of the top surface to a distalend.
 14. The apparatus of claim 13, wherein the top surface iscontiguous to the soft insole at the proximal end of the top surface.15. The apparatus of claim 13, wherein the wedge includes a proximaledge that defines ends of the top surface and the bottom surface, andthe proximal edge separates the top surface from the soft insole at theproximal end of the top surface.
 16. The apparatus of claim 8, whereinthe footwear is protective footwear.
 17. A method of suspending one ormore toes of a foot within footwear comprising: attaching a wedge havinga top surface and a bottom surface to a sole of the footwear such that adistal end of the wedge relative to the foot is aligned with and belowmetatarsophalangeal joints of the foot with the foot within thefootwear; and suspending the one or more toes off of the sole based onthe wedge being within the footwear and aligned with themetatarsophalangeal joints of the foot when the foot is within thefootwear.
 18. The method of claim 17, wherein the wedge includes abottom surface that is adapted to be affixed to the sole withinfootwear, a top surface that is adapted to be adjacent to the footwithin the footwear and to elevate the toes off of the sole, and adistal end defining ends of the bottom surface and the top surface, thedistal end being substantially aligned with the metatarsophalangealjoints of the foot.
 19. The method of claim 17, further comprising:removing a distal portion of the sole corresponding to an area of thesole below the one or more toes of the foot when the foot is within thefootwear; and forming the wedge out of the distal portion of the sole.20. The method of claim 19, further comprising: shaping the distalportion of the sole into a wedge shape, with a thick end of the wedgeshape corresponding to the distal end of the distal portion, to form thewedge.